Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
Overactive bladder (OAB) is a common condition that causes urinary urgency, frequent urination, and nocturia, which can significantly affect quality of life. Women with metabolic syndrome may have a higher risk of OAB due to vascular and metabolic abnormalities.
This study aims to evaluate the effectiveness and safety of low-energy extracorporeal shock wave therapy (LiESWT), a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants will be randomly assigned to receive either active LiESWT treatment or a sham (inactive) procedure.
Symptoms and treatment outcomes will be assessed using validated questionnaires, including the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire (ICIQ-SF), Urinary Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7), as well as a voiding diary and uroflow measurements.
The results of this study may help determine whether LiESWT is an effective treatment option for improving OAB symptoms in this patient population.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Overactive bladder (OAB) is a prevalent urological condition characterized by urinary urgency, frequency, and nocturia, which significantly impairs quality of life. Emerging evidence suggests a strong association between OAB and metabolic syndrome, which is characterized by insulin resistance, hypertension, dyslipidemia, and central obesity. These metabolic abnormalities may contribute to endothelial dysfunction, chronic inflammation, and autonomic dysregulation, potentially affecting bladder function.
Low-energy extracorporeal shock wave therapy (LiESWT) is a novel, non-invasive therapeutic modality that has been shown to promote angiogenesis, improve tissue perfusion, and modulate inflammatory responses. Previous studies have demonstrated its potential benefits in various urological conditions.
This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the efficacy and safety of LiESWT in women with metabolic syndrome-associated OAB. Participants are randomly assigned to receive either LiESWT treatment or a sham procedure.
Clinical outcomes are assessed using validated patient-reported outcome measures, including OABSS, ICIQ-SF, UDI-6, and IIQ-7, along with objective parameters such as uroflowmetry and post-void residual volume. Assessments are performed at baseline and at multiple follow-up time points after treatment.
This study aims to provide clinical evidence on the therapeutic role of LiESWT in improving symptoms and quality of life in this specific patient population.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: JIUNHUNG GENG, MD
- Número de teléfono: +88673121101 ext.6694
- Correo electrónico: u9001090@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Yung-Chin Lee, MD, PHD
- Número de teléfono: +88673121101 ext.6694
- Correo electrónico: leeyc12345@yahoo.com.tw
Ubicaciones de estudio
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Taiwan
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Kaohsiung, Taiwan, Taiwán, 807
- Reclutamiento
- Kaohsiung Medical University
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Contacto:
- JIUNHUNG GENG, MD
- Número de teléfono: +88673121101 ext 6694
- Correo electrónico: u9001090@hotmail.com
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Contacto:
- Yung-Chin Lee, MD,PHD
- Número de teléfono: +88673121101
- Correo electrónico: leeyc12345@yahoo.com.tw
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Sub-Investigador:
- Jiun-Hung Geng, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion:
- Female participants aged 20 to 75 years
- Diagnosed with overactive bladder (OAB), defined as urinary frequency (≥8 times/day), nocturia (≥2 times/night), and urgency (≥2 episodes/week) for at least 3 months
- Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
- Waist circumference ≥80 cm
- Blood pressure ≥130/85 mmHg or receiving antihypertensive treatment
- Fasting glucose ≥100 mg/dL or receiving treatment for diabetes
- Triglycerides ≥150 mg/dL or receiving lipid-lowering treatment
- High-density lipoprotein cholesterol <50 mg/dL
- No pharmacological or injection treatment for OAB within 3 months prior to enrollment
- Able to understand and comply with study procedures and questionnaires
- Willing to provide informed consent
Exclusion:
- History of kidney stones or bladder stones
- Urinary tract infection within 3 months prior to enrollment or recurrent urinary tract infections (≥3 episodes)
- Lower urinary tract surgery within 6 months prior to enrollment
- Known or suspected malignancy of the urinary tract
- Significant bladder outlet obstruction
- Severe coagulopathy, liver failure, or renal failure
- Prior pelvic malignancy or pelvic radiation therapy
- Intravesical injection or electrical stimulation therapy within the past year
- Substance abuse (drug or alcohol) within the past year
- Chronic pelvic pain due to other causes
- Inability to complete study questionnaires or procedures
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: LiESWT Group
Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.
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LiESWT is delivered using a focused shock wave device at an energy flux density of 0.25 mJ/mm², frequency of 3 Hz, and 3,000 pulses per session.
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Comparador falso: Sham Control Group
Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.
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The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Overactive Bladder Symptom Score (OABSS)
Periodo de tiempo: Baseline to 24 weeks
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The Overactive Bladder Symptom Score (OABSS; range 0-15, with higher scores indicating more severe symptoms) will be used.
The primary outcome is the change in OABSS from baseline to 4, 8, 12, 16, 20, 24 weeks after treatment.
Lower scores indicate improvement in symptoms.
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Baseline to 24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Periodo de tiempo: Baseline to 24 weeks
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The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range 0-21, higher scores indicate worse symptoms).
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Baseline to 24 weeks
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Change in Urinary Distress Inventory (UDI-6)
Periodo de tiempo: Baseline to 24 weeks
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The Urinary Distress Inventory-6 (UDI-6; range 0-100, higher scores indicate greater symptom distress).
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Baseline to 24 weeks
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Change in maximum urinary flow rate measured by uroflowmetry (Qmax)
Periodo de tiempo: Baseline to 24 weeks
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Maximum urinary flow rate (Qmax, mL/s) will be assessed using standard uroflowmetry.
Higher values indicate improved urinary flow function.
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Baseline to 24 weeks
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Change in post-void residual volume measured by bladder ultrasound (PVR)
Periodo de tiempo: Baseline to 24 weeks
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Post-void residual (PVR, mL) will be measured using bladder ultrasound immediately after voiding.
Lower values indicate improved bladder emptying.
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Baseline to 24 weeks
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Change in voided volume per micturition assessed by 3-day voiding diary
Periodo de tiempo: Baseline to 24 weeks
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Voided volume (mL) will be calculated from a 3-day voiding diary.
Higher values indicate improved bladder capacity.
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Baseline to 24 weeks
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Change in total daily urine volume assessed by 3-day voiding diary
Periodo de tiempo: Baseline to 24 weeks
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Total urine volume (mL/day) will be calculated from a 3-day voiding diary.
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Baseline to 24 weeks
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change in Incontinence Impact Questionnaire short version (IIQ-7)
Periodo de tiempo: Baseline to 24 weeks
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The IIQ-7 uses a 0-3 scale to measure how urinary incontinence impacts household chores, physical recreation, entertainment, travel, social activities, emotional health, and feelings of frustration to determine an overall quality-of-life score.
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Baseline to 24 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of treatment-related adverse events
Periodo de tiempo: Baseline to 24 weeks
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Adverse events will be recorded throughout the study period and classified according to severity and relationship to treatment.
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Baseline to 24 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yung-Chin Lee, MD,PHD, Kaohsiung Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades metabólicas
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Trastornos del metabolismo de la glucosa
- Resistencia a la insulina
- Hiperinsulinismo
- Enfermedades de la vejiga urinaria
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Síndrome metabólico
- Vejiga Urinaria Hiperactiva
- Nicturia
Otros números de identificación del estudio
- KMUHIRB-F(I)-20230051
- KMUH-LiESWT-OAB-2023 (Otro identificador: Kaohsiung Medical University Hospital)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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